ofatumumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
human origin	4951	679818-59-8

Description:

Molecule	Description
Synonyms: ofatumumab arzerra GSK1841157 HuMax-CD20 2F2	Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B cell tumours. The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complement dependent cytotoxicity and resultant lysis of tumour cells. Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of complement defence molecules. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

ofatumumab
arzerra
GSK1841157
HuMax-CD20
2F2

Ofatumumab is a human monoclonal antibody (IgG1) that binds specifically to a distinct epitope encompassing both the small and large extracellular loops of the CD20 molecule. The CD20 molecule is a transmembrane phosphoprotein expressed on B lymphocytes from the pre-B to mature B lymphocyte stage and on B cell tumours. The binding of ofatumumab to the membrane-proximal epitope of the CD20 molecule induces recruitment and activation of the complement pathway at the cell surface, leading to complement dependent cytotoxicity and resultant lysis of tumour cells. Ofatumumab has been shown to induce appreciable lysis of cells with high expression levels of complement defence molecules.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
0.67	mg	P

ADMET properties:

None

Approvals:

Date	Agency	Company
April 19, 2010	EMA	Novartis Europharm Ltd
Oct. 26, 2009	FDA	GLAXO GRP LTD
March 23, 2021	PMDA	Novartis Pharma K.K.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Chills	200.62	22.59	124	5415	113254	63370229
Influenza like illness	168.31	22.59	92	5447	66732	63416751
Multiple sclerosis relapse	154.07	22.59	78	5461	48400	63435083
Pyrexia	150.51	22.59	194	5345	470284	63013199
Accidental exposure to product	139.29	22.59	61	5478	27344	63456139
Febrile neutropenia	113.53	22.59	89	5450	118360	63365123
COVID-19	93.55	22.59	78	5461	113025	63370458
Device malfunction	88.27	22.59	39	5500	17818	63465665
Incorrect dose administered by device	84.35	22.59	26	5513	4322	63479161
Headache	67.48	22.59	161	5378	633080	62850403
Fatigue	51.92	22.59	182	5357	887846	62595637
Campylobacter infection	51.21	22.59	13	5526	1063	63482420
Progressive multifocal leukoencephalopathy	50.48	22.59	24	5515	12947	63470536
Hypogammaglobulinaemia	43.16	22.59	18	5521	7137	63476346
Multiple sclerosis	41.27	22.59	26	5513	24346	63459137
Needle issue	39.77	22.59	19	5520	10357	63473126
Injection related reaction	39.62	22.59	10	5529	799	63482684
Drug dose omission by device	39.11	22.59	15	5524	4786	63478697
Device leakage	36.67	22.59	16	5523	7080	63476403
Wrong technique in device usage process	35.74	22.59	13	5526	3585	63479898
Hypoaesthesia	33.78	22.59	56	5483	168337	63315146
Neutropenic sepsis	29.00	22.59	18	5521	16420	63467063
Muscular weakness	23.59	22.59	40	5499	122313	63361170
Hemianopia	23.08	22.59	7	5532	1100	63482383
Device defective	22.93	22.59	8	5531	1954	63481529
SARS-CoV-2 test positive	22.77	22.59	12	5527	8044	63475439

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Febrile neutropenia	177.89	24.55	136	3786	136713	34816296
Pneumonia	137.03	24.55	184	3738	362443	34590566
Pyrexia	110.56	24.55	159	3763	332854	34620155
Neutropenic sepsis	101.80	24.55	43	3879	13724	34939285
Chills	66.47	24.55	62	3860	80981	34872028
Influenza like illness	65.57	24.55	40	3882	27594	34925415
Second primary malignancy	46.44	24.55	21	3901	7865	34945144
Infusion related reaction	44.23	24.55	41	3881	53016	34899993
Disease progression	43.60	24.55	57	3865	108020	34844989
Tumour lysis syndrome	41.23	24.55	25	3897	17034	34935975
Injection related reaction	39.86	24.55	9	3913	345	34952664
Neutropenia	32.69	24.55	61	3861	156717	34796292
Multiple sclerosis relapse	31.09	24.55	19	3903	13114	34939895
Hypercalcaemia	28.24	24.55	19	3903	15449	34937560
Cytomegalovirus infection	27.36	24.55	23	3899	26112	34926897
Lymphocyte count decreased	25.96	24.55	21	3901	22601	34930408
Lower respiratory tract infection	25.47	24.55	24	3898	31613	34921396

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Febrile neutropenia	218.73	22.32	166	6209	230833	79507180
Pyrexia	200.26	22.32	257	6118	678452	79059561
Chills	175.87	22.32	126	6249	160108	79577905
Pneumonia	171.39	22.32	235	6140	660011	79078002
Influenza like illness	129.15	22.32	77	6298	71630	79666383
Neutropenic sepsis	115.69	22.32	52	6323	27012	79711001
Multiple sclerosis relapse	76.08	22.32	47	6328	46486	79691527
Progressive multifocal leukoencephalopathy	67.65	22.32	33	6342	20567	79717446
COVID-19	64.60	22.32	71	6304	157603	79580410
Second primary malignancy	59.48	22.32	27	6348	14323	79723690
Hypogammaglobulinaemia	52.52	22.32	24	6351	12927	79725086
Injection related reaction	47.81	22.32	12	6363	1024	79736989
Campylobacter infection	45.26	22.32	13	6362	1850	79736163
Tumour lysis syndrome	43.79	22.32	26	6349	23913	79714100
Neutropenia	39.27	22.32	77	6298	287633	79450380
Disease progression	39.13	22.32	60	6315	184302	79553711
Hepatitis B	29.32	22.32	14	6361	8318	79729695
Squamous cell carcinoma of skin	27.66	22.32	16	6359	14017	79723996
Infusion related reaction	25.96	22.32	57	6318	230180	79507833
Toxicity to various agents	23.52	22.32	3	6372	421537	79316476
Infection	23.02	22.32	56	6319	241656	79496357

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01FA02	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES CD20 (Clusters of Differentiation 20) inhibitors
ATC	L04AA52	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Selective immunosuppressants
FDA MoA	N0000175078	CD20-directed Antibody Interactions
MeSH PA	D000970	Antineoplastic Agents
FDA EPC	N0000175657	CD20-directed Cytolytic Antibody

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Chronic lymphoid leukemia, disease	indication	92814006
Relapsing multiple sclerosis	indication	230372003
Secondary progressive multiple sclerosis	indication	425500002	DOID:0050783

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
B-lymphocyte antigen CD20	Surface antigen	P11836	CD20_HUMAN	ANTIBODY BINDING	Kd	9.92		IUPHAR	DRUG LABEL

External reference:

ID	Source
D09314	KEGG_DRUG
4029460	VUID
N0000180305	NUI
4029460	VANDF
CHEMBL1201836	ChEMBL_ID
C527517	MESH_SUPPLEMENTAL_RECORD_UI
6778	IUPHAR_LIGAND_ID
DB06650	DRUGBANK_ID
712566	RXNORM
168892	MMSL
26825	MMSL
d07509	MMSL
013301	NDDF
444607009	SNOMEDCT_US
444609007	SNOMEDCT_US
895672000	SNOMEDCT_US
C1832027	UMLSCUI
8606	INN_ID
8254	PUBCHEM_CID
M95KG522R0	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ARZERRA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0669	INJECTION, SOLUTION	20 mg	INTRAVENOUS	BLA	26 sections
ARZERRA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0669	INJECTION, SOLUTION	20 mg	INTRAVENOUS	BLA	26 sections
ARZERRA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0669	INJECTION, SOLUTION	20 mg	INTRAVENOUS	BLA	26 sections
ARZERRA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0690	INJECTION, SOLUTION	20 mg	INTRAVENOUS	BLA	26 sections
ARZERRA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0690	INJECTION, SOLUTION	20 mg	INTRAVENOUS	BLA	26 sections
ARZERRA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0690	INJECTION, SOLUTION	20 mg	INTRAVENOUS	BLA	26 sections
KESIMPTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-1007	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	BLA	30 sections
KESIMPTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-1007	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	BLA	30 sections
KESIMPTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-1007	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	BLA	30 sections
KESIMPTA	HUMAN PRESCRIPTION DRUG LABEL	1	0078-1007	INJECTION, SOLUTION	20 mg	SUBCUTANEOUS	BLA	30 sections